Charcot Leyden Crystals in Pathology

Asthma Clinical Trial

— CLCpath  

Official title:

Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999242
• Other study ID #: RECHMPL19_0256
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

Description:

In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (> 3%) and the criteria were extended to those with circulating eosinophilia (> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 15, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Having Charcot Leyden Crystals in a pathological sample

Exclusion Criteria:

• Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'Level of asthma control/severity according to GINA stepwise approach		Baseline (day 0)
Primary	'Level of asthma control/severity according to GINA stepwise approach		Baseline (day 0) to Month 12
Secondary	Cumulative annualized dose of inhaled and systemic corticosteroids	The quantity of corticosteroids consumed during the course of a year.	Baseline (day 0) to Month 12